AzTrials
AzTrials

Breast CancerSHIFTNCT04926766

Super Hypofractionated Irradiation for Whole Breast Treatment

A study testing External Beam radiotherapy using IMRT technique in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
External Beam radiotherapy using IMRT technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
1 siteChina
Study dates
23 Jan 2021to 10 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Aged ≥18 years old
  • breast conservation surgery
  • unilateral histologically confirmed invasive breast carcinoma or Ductal Carcinoma In Situ (DCIS)
  • For patients with invasive breast cancer，negative axillary lymph nodes or micrometastasis only
  • Karnofsky Performance Status ≥80, and Life expectancy of >5 years
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  • Histologically negative surgical margin for invasive breast carcinoma or a minimum negative margin width of ≥ 3mm for DCIS
  • Surgery wound healed without infection
  • ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
  • Female patients of child-producing potential must agree to use effective contraception for up to 1 month before study treatment and the duration of study participation

Who cannot join

  • Histological involvement of supraclavicular lymph node
  • Histologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
  • Pregnant or lactating women
  • Severe non-neoplastic medical comorbidities
  • Diagnosis of non-breast malignancy within 5 years preceding enrollment (excluding lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix, Pulmonary adenocarcinoma in situ，which are permitted).
  • simultaneous contralateral breast cancer
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  • Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
  • Active collagen vascular disease
  • Definitive histological or radiologic evidence of distant metastatic disease
  • Evidence of T4 disease

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: Super Hypofractionated Irradiation for Whole Breast Treatment: a Prospective, Single-arm Trial

The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, distant metastasis, death, contralateral breast cancer and quality of life.

Read the detailed description

Eligible breast cancer patients will receive SHF-WBI of 5.2 Gy in 5 fractions to ipsilateral whole breast within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of the radiation oncologist. All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. Patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, distant metastasis, death and quality of life.

Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after SHF-WBI comparing to hypofractionated whole breast irradiation(40-42.5Gy/15-16Fx) and lost rate of follow up of 10%. In total 217 patients are needed to be recruited.

Conditions
Breast Cancer
Being tested
External Beam radiotherapy using IMRT technique
Keywords
Whole breast irradiation, IMRT, Super Hypofractionated radiotherapy, Super Hypofractionated irradiation to tumor bed boost
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External Beam radiotherapy using IMRT techniqueRadiation

    2600cGy/ 5 fractions / 1 weeks to ipsilateral whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist

Study groups in NCT04926766
Study groupRoleWhat they receive
SHF-WBIExperimentalPatients with an indication for whole breast irradiation will receive 5.2 Gy in 5 fractions to whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist
Receives: Radiation: External Beam radiotherapy using IMRT technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity

    Within time from the beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation induced toxicities will be assessed and recorded using Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

    Measured: 6 months

Secondary outcomes (7)

  1. Cumulative complication rate of ≥Grade 2 Late Radiation-induced Toxicity

    Within time from 6 months after completion of radiotherapy to 5 years after completion of radiotherapy, any late toxicity will be assessed and recorded using the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 5.0

    Measured: 5 years

  2. Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale

    The cosmetic outcomes will be evaluated at 6 months after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast

    Measured: 6 months

  3. Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale

    The cosmetic outcomes will be evaluated at 5 years after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast

    Measured: 5 years

  4. Locoregional recurrence

    any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area(including supraclavicular, infraclavicular or internal mammary lymph nodes)

    Measured: 5 years

  5. Distant metastasis free survival (DMFS)

    The time from the date of enrollment to any recurrence of tumor at distant sites or death from any cause

    Measured: 5 years

  6. Invasive recurrence-free survival (IRFS)

    The time from the date of enrollment to any invasive recurrence of tumor or death from any cause

    Measured: 5 years

  7. Overall survival

    The time from the date of enrollment to the date of death from any cause

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2021
  2. Study start23 Jan 2021
  3. Primary completion10 Jan 2024
  4. Study completion10 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
217 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04926766
Sponsor's protocol ID
SHF-WBI
Acronym
SHIFT
Status last verified
Dec 2024
First submitted
9 Jun 2021
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zheng SY, Huang JQ, Xie JR, Gan L, Yu B, Shi YG, Jiang J, Zhang J, Dong ML, Qi WX, Cai G, Cai R, Xu C, Xu HP, Qian XF, Zhang YB, Cao L, Chen JY. Early Safety of Ultra-Hypofractionated Whole Breast Irradiation and Sequential Tumor Bed Boost for Early Breast Cancer (SHIFT): A Multicenter, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2026 Aug 1;125(5):1360-1367. doi: 10.1016/j.ijrobp.2026.02.233. Epub 2026 Feb 25.

    PubMed 41759682

Questions about this trial

What is this clinical trial studying?

A study testing External Beam radiotherapy using IMRT technique in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04926766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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